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Bioanalytical

Validated bioanalytical methods must be developed before the first preclinical pharmacokinetic data can ever be obtained from animals. These are the same methods used in IND-enabling, GLP toxicology studies as well as for analysis during human clinical trials. Each time bioanalytical methods are transferred and validated, cost, time and the risk of variability and error are involved. The importance of having well developed methods, validating them per species and maintaining continuity from preclinical through clinical development studies with as little variability as possible, is of paramount importance for the success of any drug development program.

IITRI offers you a range of bioanalytical services for the detection and quantitation of both small molecule and biologic drug candidates from human clinical trial samples, and from difficult tissue matrices.

Core Services

Analytical method development and validation

Bioanalytical sample quantitation and analysis

Pharmacokinetics analysis

Dose formulation analysis

Toxicokinetic analysis and modeling

In Vitro Assays

Enzyme-linked immunoassays (ELISA)

Immunogenicity testing

Cytokine expression

Assessment of biomarkers

qPCR, RT-PCR and full suite of PCR-based assays

EpiAirway 3D human airway tissue model for inhalation toxiclogy

Key Equipment

LC-MS/MS - AB SCIEX 5500

LC-QTRAP - AB SCIEX 4000

HPLC - Waters, Agilent

Robotic Sample Prep System - TomTec Quadra 3® SPE System

FTIR - Bruker

BD FACSCelesta™ Flow Cytometer

The IITRI Advantage

Highly experienced bioanalytical team with greater than 60% of the scientists holding advanced degrees

Demonstrated success in method development for even the most difficult drug candidates

All methods conform to regulatory guidelines as well as sponsor requirements